FDA Adverse Event
Injury
Summary report: N
STABILITY PIN RET BLADE
MDR report key: 7022736
·
Received November 10, 2017
Report
- Report Number
- 1030489-2017-02316
- Event Type
- Injury
- Date Received
- November 10, 2017
- Date of Event
- March 1, 2017
- Report Date
- December 11, 2017
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- GAD
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
NO PATIENT COMPLICATIONS WERE REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING OBLIQUE LUMBAR INTERBODY FUSION AT L2-L3, L3-L4, L4-L5 THE PIN GOT BROKEN WHEN IT WAS REMOVED FROM THE L4 VERTEBRA. A PIECE OF THE PIN GOT STUCK INTO THE VERTEBRA AND IT WAS IMPOSSIBLE TO REMOVE IT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN. THERE WAS NO DELAY IN THE OVERALL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798455 | STABILITY PIN RET BLADE | RETRACTOR | GAD | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |